Trial record 3 of 1371 for:    Open Studies | "Body Weight"

Computer-Based Weight Maintenance in Primary Care (MAINTAIN-PC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret (Molly) Conroy, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01946191
First received: September 16, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to test whether online tracking tools and weight maintenance coaching visits for patients and real-time electronic progress reports for primary care providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients who have lost ≥ 5% of their body weight.


Condition Intervention
Body Weight
Weight Loss
Motor Activity
Behavioral: Health coach electronic communication and support
Behavioral: Online self-monitoring
Behavioral: Real-time updates to Primary Care physicians

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Body weight [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Change in body weight from baseline (day 1) until the end of study (36 months).


Secondary Outcome Measures:
  • Maintenance of 5% weight loss [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Secondarily, we will also assess the maintenance of a 5% weight loss from baseline (day 1) to end of study (36 months).

  • BMI [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Change in body mass index from baseline (day 1) to the end of the study (36 months).


Other Outcome Measures:
  • Patient Satisfaction [ Time Frame: 12 Months and 36 Months ] [ Designated as safety issue: No ]
    Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (36 months).

  • PCP Satisfaction [ Time Frame: 12 Months and 36 Months ] [ Designated as safety issue: No ]
    PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (36 months).


Estimated Enrollment: 196
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continued Coaching (CC)
Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians
Behavioral: Health coach electronic communication and support
Health coach reviews responses to weight-related surveys and provides feedback and advice
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Behavioral: Real-time updates to Primary Care physicians
Primary care physicians will receive updates through electronic health record system before each scheduled appointment
Active Comparator: Tracking Only (TO)
Online self-monitoring
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • Intentional & verified weight loss of greater than or equal to 5% of body weight in past two years with previous BMI greater than or equal to 25.
  • Patient of participating PCP
  • Has/willing to get electronic personal health record account

Exclusion Criteria:

  • Unable to perform moderate exercises according to PCP
  • Current or planned pregnancy
  • Currently breastfeeding
  • Recent or planned bariatric surgery
  • Edema due to medical condition
  • No access to computer
  • Treated for cancer or thyroid disease in past year
  • Unable to attend group session or comply with requirements
  • Any other reason as determined by the Principal Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946191

Contacts
Contact: Kimberly A Huber, MPH 412-605-0683 MAINTAIN@pitt.edu

Locations
United States, Pennsylvania
Center for Research on Health Care Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly A Huber, MPH    412-605-0683    MAINTAIN@pitt.edu   
Principal Investigator: Margaret B Conroy, MD, MPH         
Sub-Investigator: Kathleen M McTigue, MD, MS         
Sub-Investigator: Rachel Hess, MD, MSc         
Sub-Investigator: Cindy Bryce, PhD         
Sub-Investigator: Gary Fischer, MD         
Sub-Investigator: Dana Tudorascu, PhD         
Sub-Investigator: Laurey R Simkin-Silverman, PhD, MA         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Margaret B Conroy, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Margaret (Molly) Conroy, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01946191     History of Changes
Other Study ID Numbers: 1R18HS021162
Study First Received: September 16, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Weight maintenance
Electronic health record
Primary care

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 22, 2014